Therafectin amiprilose Hcl data

BLSI announced that Phase III findings with Therafectin failed to demonstrate a statistically significant difference in the primary end point. The percent of patients achieving a return to baseline or better in the number of painful joints, swollen joints, and global assessments at final visit was 40 and 33 respectively for the treatment and placebo groups. A significant difference in a secondary end point, number of swollen joints, was achieved (p<0.007). No adverse events were attributed to the agent.

The company will assemble a panel of rheumatologists to advise on whether an amendment should be submitted to the NDA that is pending with the FDA. ...